Enantiomeric Determination of Drugs in Pharmaceutical Formulations and Biological Samples by Electrokinetic Chromatography

Abstract

Chirality is a relevant issue in the pharmaceutical field due to the different biological activity that enantiomers of a chiral drug can show. In fact, the desired biological or pharmaceutical activity might be present in only one of the enantiomers, while the other enantiomer(s) may have different biological activity, be inactive or even toxic. This has motivated in recent years the development of drugs marketed as pure enantiomers to avoid exposing the organism to the action of enantiomers that may not be active or even harmful to health. Thus, it is of high interest to develop enantioselective analytical methodologies to control the presence of enantiomeric impurities and to understand the enantioselective metabolism of chiral drugs. This review gives an overview about the analytical strategies developed by electrokinetic chromatography (EKC) from 2010 to June 2019 for the enantiomeric determination of drugs in both pharmaceutical formulations and biological samples. The types of chiral selectors used, the migration order of enantiomers, their resolution, the detection technique employed and the sensitivity achieved are revised and compared. Also, applications to assess the enantiomeric purity control of pharmaceutical formulations and to determine chiral drugs in biological samples to study their metabolism are included. Advantages and limitations of the chiral methods developed by EKC are also discussed.

Keywords:

• Biological samples
• chiral selectors
• drugs
• electrokinetic chromatography
• enantiomers pharmaceutical formulations

Disclosure statement

The authors declare no conflicts of interest.

Additional information

Funding

Authors thank the Spanish Ministry of Economy and Competitiveness for project CTQ2016-76368-P.